Effect of PRM-125 on Ambulatory Blood Pressure | NCT05195827

Studies
Effect of PRM-125 on Ambulatory Blood Pressure

NCT05195827

Sponsor

PRM Pharma, LLC

Status

Withdrawn

Last Update Posted

Mar 20, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

PRM-125

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor

Expanded Access Info

Start Date

Dec 20, 2021Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Jan 2, 2022

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension

Detailed Description

Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRM125	Experimental	PRM125	Drug: PRM-125

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRM-125	Drug	Antihypertensive	PRM125

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in 24 hour Systolic Blood Pressure		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in 24 hour Diastolic Blood Pressure		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary hypertension

Exclusion Criteria:

medical conditions that preclude evaluation and/or adversely effect subject safety

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AMR		Coral Gables	Florida	33134	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided